Safety limits for closed-loop infusion pump control

ABSTRACT

A system and process for providing safety limits on the delivery of an infusion formulation by an infusion pump system in response to a sensed biological state. The safety limits may comprise user-initiated event signals corresponding to events that may significantly affect the biological state. The safety limits may further comprise user-initiated event ranking signals for respective events which specify a degree, quantity, or measure for the respective event. The user-initiated event and event ranking signals may be communicated to a computing element associated with the infusion pump by an associated communication device having a user interface which comprises a plurality of user-selectable operators for entering information about the events and event rankings.

RELATED APPLICATIONS

Embodiments of the present invention claim priority from U.S.provisional application No. 60/318,062 (Attorney Docket 047711-0264),filed Sep. 07, 2001, and relates to U.S. provisional patent applicationentitled “System and Method For Providing Closed-Loop InfusionFormulation Delivery,” (Attorney Docket No. 047711-0269), filed Oct. 23,2001, the content of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to infusion pump systems for thedelivery of infusion formulations and, in particular, to an implantableinfusion pump system and process for delivering insulin to a user basedin part on user-initiated signals which correspond to events which mayaffect the glucose level of the user.

2. Description of Related Art

In the medical arts, implantable infusion pumps are used for theprogrammed delivery of measured doses of an infusion formulation. (Aninfusion formulation is defined in the present disclosure as thesubstance being delivered by the infusion pump. This substance maycomprise either a mixture of different components or it may be a single,pure substance.) A typical example of such use is the intraperitonealdelivery of an insulin formulation. FIG. 1 illustrates an example ofthis use. As shown in FIG. 1, an implantable infusion pump (IIP) 10 maybe implanted in a patient below the skin and above the muscle in theabdomen. The IIP 10 will then dispense an infusion formulation (such asan insulin formulation) through the peritoneum wall 12 via a catheter14. A lead 16 may connect IIP 10 to a sensing device (not shown) that isused to regulate the delivery of the infusion formulation.

In the case where the infusion formulation is an insulin formulation,the sensing device may regulate the delivery of the insulin formulationby sensing the levels of glucose in the patient. The delivery of theinsulin formulation may then be performed in two ways. Information aboutthe sensed glucose level may be provided to the patient (or to thepatient's physician) through a communication device associated with thepump. The patient (or physician) would then manually administer anappropriate amount of the insulin formulation in accordance with thesensed glucose level. Alternatively, the sensed glucose level may beprovided to a control device associated with the pump (such as aprocessor or other computing element) for controlling activation of thepump to deliver an appropriate amount of the insulin formulation inaccordance with the sensed glucose level.

As discussed above, a typical use for an implantable infusion pump isthe intraperitoneal delivery of an insulin formulation. Insulin is aprotein hormone normally formed within the human pancreas. Because itregulates carbohydrate (sugar) metabolism, insulin is required fornormal metabolic function. More specifically, insulin helps the bodyprocess glucose. To avoid medical problems, glucose levels should bemaintained within a specific range. A normal range for glucose in thehuman body may be between 85 and 120 mg/dl.

In a non-diabetic person, insulin is secreted by the pancreas in smallamounts throughout the day (basal rate of insulin secretion). Inaddition, the amount of insulin secreted by the pancreas may be modifiedunder certain circumstances. For example, the pancreas of a non-diabeticperson normally secretes larger amounts of insulin (bolus rate ofinsulin secretion) when the person ingests a meal to preventpostprandial hyperglycemia, i.e., abnormally increased sugar content inthe blood.

In contrast to the non-diabetic person, a diabetic person's pancreas maynot secrete the required amount of insulin. Thus, the diabetic personhas to somehow artificially introduce the insulin into the body. Onemethod of introducing the insulin is by the conventional insulinformulation injection method using a syringe. Using this method, thebody's glucose level may be monitored (for example, by checking a bloodsample) and the amount of insulin to be injected may be adjustedaccordingly. For example, after a meal the glucose level may bemonitored and an appropriate amount of insulin may be injected into thebloodstream of the individual.

In the alternative, a diabetic person may choose to use an infusion pumpsuch as the implantable infusion pump described above and shown inFIG. 1. By using an infusion pump, a diabetic person may be able toadjust insulin delivery rates for the pump in accordance with the user'sneeds. These needs may be determined based on prior experience and/orthe results of glucose monitoring (for example, by a sensing device incombination with a communication device). As an example, the basal andbolus delivery rates of an infusion pump may be adjusted in this manner.

In addition, infusion pumps may be engineered to function as anartificial pancreas. Such an infusion pump may deliver a specific amountof insulin formulation at specific intervals. As discussed above, asensing device associated with the pump may monitor the glucose level ofthe user and the glucose level may then be used by the pump toautomatically regulate the delivery of the insulin formulation. Theautomatic regulation may be carried out by a processor or othercomputing element associated with the pump.

The processor or other computing element may execute a closed-loopalgorithm which may adjust insulin formulation delivery as a functionof, for example, the rate of change over time of a sensed glucose level.These processes may be transparent to the user. Thus, the infusion pumpin combination with a sensing device and closed-loop algorithm may bevery beneficial to a diabetic person by automating the tasks ofmonitoring glucose levels and introducing an appropriate amount ofinsulin formulation based on the glucose level, with minimal input fromthe user (or the user's physician).

However, a problem exists with the method described above for theautomated delivery of insulin using an infusion pump. The problemresults from the fact that an individual's glucose level may besignificantly affected by certain daily events. For example, when aperson ingests food, glucose levels may rise due to ingestedcarbohydrates (sugars). In addition, it is believed that sleep affectsglucose levels due to changes in the rate of glucose metabolism when aperson sleeps. An individual's stress level may also affect glucosemetabolism by increasing glucose levels in the bloodstream. Furthermore,the ingestion of medications may affect glucose levels within the body.

A properly functioning sensing device may detect a change in glucoselevel due to any of the events described above and provide the change inglucose level as an input to the closed-loop algorithm which may, inturn, provide an output to the pump to properly adjust the delivery ofinsulin formulation accordingly. However, in the case of an erroneousinput to the closed-loop algorithm, for example, as a result of amalfunctioning sensing device, an erroneous glucose level may beindicated, leading to an erroneous adjustment in the amount of insulindelivered to the pump user. Under certain circumstances, such an errormay result in extreme harm (including death) to the pump user.

Furthermore, it is believed that the body of a person merelyanticipating the ingestion of a meal may have an increased level ofinsulin secretion. This increased insulin secretion may occur before anyincrease in glucose level can be detected by a sensing device. It isfurther believed that one reason for this leading insulin secretionreflex may be that the body is compensating, by early release of theinsulin, for the time required for the insulin to react with theglucose. The secretion of insulin associated with meal anticipation isbelieved to lead any significant rise in glucose level by as much as15-20 minutes. With present infusion pump systems for delivery ofinsulin formulation, such leading insulin secretion reflex may not bereplicated, because the delivery of insulin by the pump may not occuruntil triggered by the detection of glucose by the sensing device.

Accordingly, there is a demand for an infusion pump system and processfor delivery of insulin formulation which provides safety limits thatmay be used in conjunction with a closed-loop algorithm for adjustinginsulin formulation delivery. The safety limits verify that levels ofglucose detected by the infusion pump system's sensing device areconsistent with events that may significantly affect the glucose level.In addition, there is a need for an infusion pump system and process fordelivery of insulin formulation which may more accurately replicate thebody's leading insulin secretion reflex.

SUMMARY OF THE DISCLOSURE

Therefore, it is an advantage of embodiments of the present invention toprovide safety limits on the delivery of infusion formulation inresponse to a detected biological state, the safety limits being in theform of user-initiated signals corresponding to events that maysignificantly affect the biological state.

It is a further advantage of embodiments of the present invention toenable a user to initiate delivery of an insulin formulation before achange in a glucose level is detected in order to simulate a naturallyoccurring leading insulin secretion reflex.

It is a further advantage of embodiments of the present invention toprovide diagnostic checks which compare an actual detected change inbiological state with a change that is expected based on auser-initiated signal and alert a user to a possible malfunction whenthe results of the comparison are not within pre-determined limits.

It is a further advantage of embodiments of the present invention toalert a user if a detected biological state exists which should notexist in the absence of a user-initiated signal.

It is a further advantage of embodiments of the present invention toprovide a user with a history of user-initiated signals, the historybeing accessible to the user and/or the user's physician.

These and other advantages are accomplished according to a system andprocess for communicating safety limits to a computing element in aninfusion pump system. The safety limits may be communicated to thecomputing element in the form of user-initiated signals corresponding toinformation about events which may affect a biological state. Thecomputing element may execute a closed-loop algorithm for adjusting thedelivery of an infusion formulation base on a sensed biological state.

Preferred embodiments of the present invention provide a communicationdevice for use with an infusion pump system for the peritoneal deliveryof an insulin formulation to a diabetic user. In preferred embodiments,the communication device comprises a user interface having a pluralityof user-selectable operators whereby a user may communicate informationto the computing element about events that may affect a glucose leveldetected by a sensing device in the infusion pump system.

Depending upon the context of use, the invention may include variouscombinations of these features which function together to provide safetylimits on the delivery of infusion formulation in response to a detectedbiological state. Various embodiments of the invention include one ormore of these features. Preferred embodiments of the present inventioncontain each of these features.

These and other objects, features, and advantages of embodiments of theinvention will be apparent to those skilled in the art from thefollowing detailed description of embodiments of the invention, whenread with the drawings and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a fragmented cutaway view of an exemplary environment ofuse for embodiments of the present invention in the peritoneal deliveryof an insulin formulation.

FIG. 2 shows a flowchart of a closed-loop algorithm for adjustinginsulin formulation delivery as a function of the rate of change overtime of a sensed glucose level and/or a user-initiated signal accordingto an embodiment of the invention.

FIG. 3 shows an exemplary communication device user interface comprisinga plurality of user-selectable operators corresponding to particularevents, according to an embodiment of the invention.

FIG. 4 shows an exemplary communication device user interface comprisinga plurality of user-selectable operators for selecting various eventrankings corresponding to particular events, according to an embodimentof the invention.

FIG. 5 shows an exemplary communication device user interface comprisinga display for displaying events and event ranking information to a user,along with user-selectable operators for selecting and entering theevents and event ranking information, according to an embodiment of theinvention.

FIG. 6 shows an exemplary communication device user interface comprisingan event ranking selection screen, according to an embodiment of theinvention.

FIG. 7 shows an exemplary communication device user interface comprisinga display for entering detailed dietary information about a meal event,according to an embodiment of the invention.

FIG. 8 shows an exemplary communication device user interface comprisinga display for displaying a menu of selectable food types, according toan embodiment of the invention;

FIG. 9 shows an exemplary communication device user interface comprisinga display for displaying a menu of foods corresponding to a selectedfood type, according to an embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In the following description of preferred embodiments, reference is madeto the accompanying drawings which form a part hereof, and in which isshown by way of illustration specific embodiments in which the inventionmay be practiced. It is to be understood that other embodiments may beutilized and structural changes may be made without departing from thescope of preferred embodiments of the present invention.

Environment of Use

As discussed above, the present invention relates generally to infusionpump systems for the delivery of infusion formulations. The inventionmay be employed in various infusion environments including, but notlimited to a biological implant environment. In preferred embodiments,the infusion pump system and process is configured for an implantenvironment within a human body, as shown in FIG. 1. However, otherembodiments may be employed in other biological implant or non-implantenvironments.

Furthermore, in preferred embodiments, the infusion pump system andprocess is configured for delivery of an insulin formulation used toregulate glucose levels in a diabetic user. However, other embodimentsmay be employed in the delivery of other infusion formulations havingother pharmacological properties.

As discussed above, FIG. 1 shows IIP 10 according to an embodiment ofthe invention. IIP 10 may be configured to be surgically implanted intoa user, for example, at a particular location in the venous system,along the spinal column, in the peritoneal cavity, or other suitablesite to deliver an infusion formulation to the user. However, furtherembodiments of the invention may be implemented as external infusionpumps, which connect to patients through suitable catheter devices orthe like.

Infusion Pump System

The infusion pump system according to preferred embodiments of theinvention employs a pump for delivering measured doses of an infusionformulation. In one embodiment, the pump comprises an electromagneticmechanism that is activated to selectively drive infusion formulation tothe user. The pump may be activated according to a programmed dispensingrate or schedule, or according to an actuation signal from a sensingdevice, timer, manual operator or other suitable means. In one preferredembodiment, the pump may be activated by a control signal communicatedto the pump from a computing element which may be included in theinfusion pump system.

The infusion pump system according to preferred embodiments of theinvention further employs a sensing device for monitoring a selectedbiological state. In one embodiment, the selected biological state to bemonitored may be the glucose level detected in the body of the pumpuser.

The infusion pump system according to preferred embodiments of theinvention further employs a computing element which may, along withother pump control functions, execute a closed-loop algorithm which maycontinuously adjust infusion formulation delivery as a function of thesensed biological state. In one preferred embodiment, the closed-loopalgorithm may continuously adjust insulin formulation delivery as afunction of the rate of change of glucose levels over time. Thecomputing element may comprise one or more programmable processors,logic circuits, or other hardware, firmware or software componentsconfigured for implementing the control functions described herein.

The infusion pump system according to preferred embodiments of theinvention further employs a communication device for communicatinguser-initiated signals to the computing element. The user-initiatedsignals may be representative of events that affect the selectedbiological state. In one preferred embodiment, the communication devicecommunicates with the computing element via a radio frequency (“RF”)transceiver. However, in other embodiments other suitable means of datacommunication may be employed, such as, for example, ultrasonics.

Events Affecting Glucose Levels

As discussed above, certain events may significantly affect glucoseproduction levels in the human body. Thus, these events may alsosignificantly affect the amount of insulin produced in order tometabolize the glucose. For example, the ingestion of food maysignificantly increase the production of glucose in the body. Thisresults in part from the fact that during digestion carbohydrates arebroken down into glucose that then enters the bloodstream.

In addition, the amount and type of foods ingested affect the amount ofglucose produced.

Similarly, exercise has been shown to lower glucose levels in the humanbody. Thus, exercise may result in a dip in glucose levels and acorresponding decrease in the amount of insulin formulation delivered bythe body. Longer or more strenuous exercise events may result in agreater dip in glucose level than shorter and less strenuous exerciseevents.

Furthermore, sleep and stress may affect the body's ability to burncarbohydrates and therefore may affect glucose levels. For example,glucose metabolism has been found to be slower in a sleep deprivedstate. In addition, elevations of certain stress hormones within thebody may also result in slower glucose metabolism. Thus, longer orshorter periods of sleep or stress may result in more or lesssignificant changes in glucose levels.

An additional event that may affect insulin production is the ingestionof medication. Certain medications may affect an individual'ssensitivity to insulin, i.e. a given amount of insulin may be more orless sufficient depending on whether a particular medication has beentaken. The insulin sensitivity level of a user to a particularmedication may be determined either by the user or by the user'sphysician, for example, by observing the user's glucose level aftertaking a particular medication.

Closed-Loop Algorithm Safety Limits

An infusion pump system for the automatic regulation of the delivery ofinsulin formulation should detect changes in glucose levels that mayresult from any of these events and adjust the amount of insulinformulation delivered accordingly. In an exemplary infusion pump systemfor the automatic regulation of the delivery of insulin formulation, asensing device used in conjunction with the infusion pump may detectchanges in the glucose level and provide this information as an input toa closed-loop algorithm. The typical closed-loop algorithm may thenaccordingly adjust the amount of insulin formulation delivered to theuser.

However, dangers exists in the typical infusion pump system for theautomatic regulation of the delivery of insulin formulation. One of thedangers is that the input to the closed-loop algorithm may be erroneous.In typical existing infusion pump systems for the automatic regulationof the delivery of insulin formulation, there may be no safety limits onthe amount of insulin formulation that is delivered based on anerroneous input. In other words, the typical closed-loop algorithm mayonly examine the glucose level input and may have no way to verifywhether the change in glucose level is a reasonable change, i.e., onethat is consistent with an event affecting glucose levels.

Furthermore, as discussed above, the human body shows evidence of aleading insulin secretion reflex in response to anticipation of theingestion of a meal. Typical existing infusion pump systems for theautomatic regulation of the delivery of insulin formulation may notreplicate this reflex, because the delivery of insulin formulation bythe pump may not occur until triggered by the detection of glucose bythe sensing device.

Therefore, according to preferred embodiments of the infusion pumpsystem and process, the communication device comprises a user interfacefor entering user-initiated signals representative of events which mayaffect glucose levels in a biological system such as the human body. Theuser-initiated signals are provided to a computing element within thesystem which executes a closed-loop algorithm for adjusting insulinformulation delivery as a function of, for example, the rate of changeover time of a sensed glucose level.

FIG. 2 shows a flowchart of a closed-loop algorithm for adjustinginsulin formulation delivery as a function of the rate of change overtime of a sensed glucose level which incorporates one embodiment of theinvention's system and process. As shown in step 202, the closed-loopalgorithm may continuously check for changes in glucose level. A sensingdevice may detect the change in glucose level and may communicate thechange to the computing element as a glucose level input to thealgorithm. If no change is detected, the closed-loop algorithm may loopback to step 202, repeating this process until a change is detected.When a change occurs, the closed-loop algorithm may determine whetherthe amount of insulin formulation required based on the change inglucose level is within normal basal limits for the user, as shown instep 204.

The normal basal limits for the user may have been pre-programmed intothe algorithm by the user or the user's physician. The normal basallimits may include maximum and minimum values of insulin formulationthat may be delivered at one time. For example, if the user is in abasal state (i.e., a state requiring a basal rate of insulin secretion),the closed-loop algorithm may limit the delivery of insulin formulationto a maximum of fifty percent higher than a pre-programmed nominal basalrate of delivery. Similarly, the closed-loop algorithm may not allow thedelivery rate to drop below a minimum allowable rate, for example, 0.2units per hour.

Furthermore, the user (or the user's physician) may pre-program a user'sbasal profile into the closed-loop algorithm. This basal profile mayindicate to the closed-loop algorithm, for example, that the user has alower need for insulin at night.

Referring again to FIG.2, if the change in glucose level requires anamount of insulin formulation that is within the pre-programmed basallimits and profile, the closed-loop algorithm may make a suitableadjustment to the delivery rate, as shown in step 206. The closed-loopalgorithm may then loop back to step 202, repeating steps 204 through206 described above.

However, if the detected change in glucose level requires the deliveryof an amount of insulin formulation not within the basal limits orprofile of the user, the closed-loop algorithm may scan “event inputs”to the closed-loop algorithm in order to determine if a user-initiatedsignal is present, as shown in step 208. If a user-initiated signal ispresent, the closed-loop algorithm may then process the signal todetermine the adjustment in the insulin formulation delivery rate thatcorresponds to the user-initiated signal that is present at the eventinput, as shown in step 210.

On the other hand, in one embodiment, if no user-initiated signal ispresent at the event input to the closed-loop algorithm, the user may bequeried, for example, via the communication device user interface,whether an event has occurred which requires the user to communicate asignal to the computing element, as shown in step 212. The communicationdevice user interface may include user-selectable responses to thequery.

If the user confirms that an event has occurred, as shown in step 214,the user may then be prompted to select the event, as shown in step 216.Once the user-initiated signal corresponding to the selected event isreceived at an event input of the closed-loop algorithm. The closed-loopalgorithm may then process the signal to determine the adjustment in theinsulin formulation delivery rate that corresponds to the user-initiatedsignal that is present at the event input, as shown in step 218.

In one preferred embodiment, if the user does not confirm that an eventrequiring an insulin formulation delivery amount outside of thepre-programmed basal limits has occurred, the closed-loop algorithm mayalert the user to a possible malfunction in the infusion pump system, asshown in step 220. The closed-loop algorithm may then cease automaticcontrol of the infusion pump and return to a manual operation so thatthe user or the user's physician may control the delivery rate.

Furthermore, in one preferred embodiment, the closed-loop algorithm maybe programmed to perform diagnostic checks to ensure that auser-initiated signal communicated to an event input of the closed-loopalgorithm is consistent with the glucose level detected by the sensingdevice. For example, if the user enters a meal event and the sensingdevice does not detect a corresponding change in the glucose levelwithin a pre-programmed time, the closed-loop algorithm may alert theuser to a possible malfunction in the infusion pump system. Theclosed-loop algorithm may then cease automatic control of the infusionpump and return to a manual operation so that the user or the user'sphysician may control the delivery rate.

As shown by the flowchart in FIG. 2, embodiments of the invention'ssystem and process advantageously incorporates safety limits into theclosed-loop algorithm to ensure that insulin formulation deliveryamounts outside of a pre-programmed normal basal delivery ratecorrespond to events which may significantly affect glucose level. Theseevents may be communicated by the user to the closed-loop algorithmevent inputs via a communication device user interface. In one preferredembodiment, the events that may significantly affect glucose levels maycomprise, for example, a meal event, an exercise event, a sleep event, astress event, and a medication event.

Communication Device User Interface

The events may be communicated by the user to the closed-loop algorithmevent inputs via a communication device user interface. User-selectableoperators may be provided on the communication device user interfacewhich allow a user to initiate a signal representing an event.

Thus, for example, the user may be able to press or otherwise select auser-selectable operator representing a sleep event before the usersleeps. In preferred embodiments, the closed-loop algorithm accepts theuser-initiated signal at an event input and verifies that the glucoselevel input provided by the sensing device is consistent with thepresence of the user-initiated signal at the event input of theclosed-loop algorithm, as described above in relation to FIG. 2.

In one preferred embodiment, a user-initiated signal may initiatechanges in the delivery amount of the infusion formulation independentlyof the sensing device input. For example, in one embodiment, a user mayselect a “meal” user-selectable operator on the user interface when theuser is about to consume a meal. The user-initiated signal correspondingto the meal event communicated to the computing element may theninitiate an immediate bolus delivery of insulin formulation by the pumpeven though the sensing device has not yet detected any rise in theglucose level.

Thus, the naturally occurring leading insulin secretion reflexphenomenon may be advantageously replicated by preferred embodiments ofthe infusion pump system and process by programming the closed-loopalgorithm to deliver a suitable amount of insulin formulation based onthe signal initiated by the user selecting the “meal” user-selectableoperator, without the sensing device detecting any rise in glucoselevel.

In other preferred embodiments, the user interface may compriseuser-selectable operators for selecting an “event ranking,” for example,a degree, quantity, or measure of the selected event. As an example, ifthe user has selected a meal event, the user may be able to supplementthis event information by selecting the size of the meal, for example,“light,” “moderate,” or “heavy.” In addition, in some preferredembodiments, the user may be able to further supplement the eventinformation by entering dietary information about the meal. For example,the user may be able to enter the meal's carbohydrate content, fatcontent, or other dietary information about the meal to be consumed.This information may be used to more accurately determine the expectedeffect of the meal on the glucose level.

In yet other preferred embodiments, if the user initially inputs onesize for a meal but later decides to eat more or less, the user may beable to update the meal information although delivery of the insulinformulation by the infusion pump is already in progress based on theinitial input. This may be done, for example, by selecting and inputtingthe event ranking which corresponds to the new size of the meal. In thisembodiment, the computing element may dynamically (i.e. while deliveryis in progress) re-calculate the amount of insulin formulation deliveredbased on both inputs.

As an example of this embodiment, the user may first select a light mealand input a corresponding signal. Then, after delivery is in progress,the user may decide that a heavy meal is preferable. The user may thenselect and input the event ranking which corresponds to a heavy meal.The computing element may then dynamically adjust the amount of insulinformulation delivered based on both the light and heavy inputs.

Similarly, the user interface may comprise user-selectable operators forselecting an event ranking for an exercise event. As an example, if theuser has selected an exercise event, the user may be able to supplementthis event information by selecting the type of exercise, the durationof the exercise, and/or whether the exercise is “light,” “moderate,” or“heavy.”

In addition, the user interface may comprise user-selectable operatorsfor selecting an event ranking for a sleep event. As an example, if theuser has selected a sleep event, the user may be able to supplement thisevent information by selecting the amount of time the user expects tosleep.

Alternatively, the user may select an event ranking such as, but notlimited to, “short,” “moderate,” or “long,” corresponding to a short,moderate, or long interval of sleep. As an additional example, the usermay simply press a “sleep” user-selectable operator before the sleepevent and a “wake” user-selectable operator when the user awakes. Inaddition, or in the alternative, some preferred embodiments may enablethe user to enter a time when the user expects to wake and the computingelement may automatically calculate the duration of the sleep event andadjust the amount of delivered insulin formulation accordingly.

The user interface may further comprise user-selectable operators forselecting an event ranking for a stress event. As an example, if theuser has selected a stress event, the user may be able to supplementthis event information by selecting the ranking of stress, for example,“light,” “moderate,” or “heavy.”

Furthermore, the user interface may comprise user-selectable operatorsfor selecting an event ranking for a medication event. As an example, ifthe user has selected a medication event, the user may be able tosupplement this event information by selecting the type of medicationand/or the amount of the medication.

Alternatively, the user interface may comprise user-selectable operatorswhich enable the user to, for example, simply select a level ofsensitivity to insulin that is associated with the ingestion of aparticular medication. A particular user's insulin sensitivity levelassociated with the ingestion of a particular medication may have beenpreviously determined either by the user or by the user's physician. Forexample, a particular user's insulin sensitivity level may have beenpreviously determined by observing the user's glucose level after takingthe medication. Thus, the medication event ranking may be, for example,“low,” “moderate,” or “high,” corresponding respectively to a low,moderate, or high sensitivity to insulin after taking a particularmedication.

In one embodiment, the user-initiated signals are communicated to thecomputing element where they may be provided as an input to theclosed-loop algorithm. The closed-loop algorithm may then incorporatethe user-initiated signals into the algorithm's calculation of insulinformulation output, as described in reference to FIG. 2.

FIG. 3 illustrates an example of a communication device user interfaceaccording to one preferred embodiment. In preferred embodiments, thecommunication device 300 is provided with a power source, for example, abattery, independent of the infusion pump power source. In otherembodiments, the communication device 300 may be powered from theinfusion pump power source.

Communication device 300 comprises an outer case or housing. This caseor housing may be plastic, metal, or any other suitable material.Situated on the outer housing is the user interface. In the presentpreferred embodiment, the user interface comprises a plurality ofuser-selectable operators, each of the plurality of user-selectableoperators corresponding to a particular event. Thus, communicationdevice 300 comprises a simple user interface which enables a user toselect an event simply by pressing or otherwise selecting thecorresponding user-selectable operator.

In one preferred embodiment, the user may confirm the selection of anevent by selecting an “enter” user-selectable operator 314. Theinclusion of the “enter” user-selectable operator 314 may provide ameasure of safety against accidental selection of an eventuser-selectable operator by, for example, bumping the communicationdevice against another object. Thus, both the user-selectable operatorcorresponding to the desired event and the “enter” user-selectableoperator 314 must be depressed in succession in order for a signal to becommunicated to the computing element. In another embodiment, aconfirmation screen may be used for a particularly important event, suchas, for example, delivering a bolus. For example, upon the entering of alarge meal event, the screen may respond by displaying “Large MealEntered. Confirm?” Then, the user may depress enter again to confirm theevent. This operation provides an extra level of safety.

In other embodiments, the “enter” user-selectable operator may be absentand other safety measures used against accidental selection. Forexample, in one embodiment, the user-selectable operators may besituated in a recessed portion of the communication device housing inorder to avoid accidental selection. The user may be provided with aselection device, for example, a wand or pointer device, in order toaccess the user-selectable operators. In yet other embodiments, bothsafety measures may be employed.

In the embodiment of the communication device user interface shown inFIG. 3, a user may select the “meal” user-selectable operator 302 andthen select the “enter” user-selectable operator 314 in order tocommunicate a signal to the computing element that the user is about toingest a meal or is currently ingesting a meal. The closed-loopalgorithm may then receive the user-initiated signal as an event input.In preferred embodiments, the computing element may confirm that theuser-initiated signal was received, for example, by beeping, displayinga “signal received message,” or other suitable method of informing theuser that the computing element has received the signal.

Similarly, the user may select user-selectable operators 304, 306, 308,310, or 312 in order to select the “exercise,” “sleep,” “wake,”“medication,” and “stress” events, respectively, and then select the“enter” user-selectable operator 314 in order to communicate therespective signal to the computing element that the user is about toexercise, is about to sleep, is now awake after sleeping, has takenmedication, or is experiencing stress.

The embodiment of the communication device user interface shown in FIG.3, advantageously provides the user with a user-friendly interface forcommunicating event information to the computing element. The amount ofevent information communicated to the computing element is kept to aminimum. However, embodiments of the infusion pump system and processmay advantageously use even this minimal amount of event information toprovide safety limits to insulin formulation delivery. For example, inone preferred embodiment using the communication device user interfaceshown in FIG. 3, the user's physician may be provided withpassword-protected access to the user's communication device in order tomodify the closed-loop algorithm in accordance with parameters specificto the user.

As an example, a physician may determine the impact that taking aparticular medication may have on the user's insulin sensitivity. Thephysician may then program the closed-loop algorithm in such a way thatwhen the event input to the closed-loop algorithm receives auser-initiated signal corresponding to the “medication” user-selectableoperator 310, the closed-loop algorithm may adjust the insulinformulation delivery in accordance with the physician's programmedinstructions.

Similarly, the physician may modify the closed-loop algorithm to respondin a particular way to the selection by the user of user-selectableoperators corresponding to other events. In addition, in some preferredembodiments, the computing element may maintain a history ofuser-initiated events that may be accessed by the user and/or thephysician. For example, a history of the pump user's “meal” events maybe maintained and accessed by the physician. The physician mayadvantageously use this information to advise the user on, for example,lifestyle patterns that may be affecting the user's health andwell-being.

FIG. 4 illustrates an example of a communication device user interfaceaccording to another preferred embodiment. Communication device 400 isprovided with a power source, for example, a battery, independent of theinfusion pump power source. In other embodiments, the communicationdevice 400 may be powered from the infusion pump power source.

Communication device 400 comprises an outer case or housing. This caseor housing may be plastic, metal, or any other suitable material.Situated on the outer housing is the user interface. In the presentpreferred embodiment, the user interface comprises a plurality ofuser-selectable operators for selecting various event rankingscorresponding to particular events. The events may be indicated on thecommunication device 400 user interface by printed words, pictures, orother indicia representing the event. As an example, in FIG. 4, theevents are indicated vertically along the left side of the communicationdevice 400 user interface as “meal” 402, “exercise” 410, “stress” 418,“sleep” 426, and “medication” 434.

Event rankings associated with each event are situated to the right andin the same row as the associated event. In the embodiment shown in FIG.4, the event indicators are not selectable but merely indicate the eventassociated with the user-selectable operators located in that particularrow. For example, “meal” 402 event indicator is not selectable, butmerely indicates that event rankings “light” 404, “moderate” 406, and“heavy” 410, located in the row indicated by reference numeral 401, areevent rankings associated with the “meal” 402 event.

Similarly, event rankings “light” 412, “moderate” 414, and “heavy” 416are event rankings associated with the “exercise” 410 event; eventrankings “light” 420, “moderate” 422, and “heavy” 424 are event rankingsassociated with the “stress” 41 8 event; event rankings “short” 428,“moderate” 430, and “long” 432 are event rankings associated with the.“sleep” 426 event; and event rankings “low” 436, “moderate” 438, and“high” 440 are event rankings associated with the “medication” 434event.

In addition to the event ranking user-selectable operators describedabove, the communication device 400 user interface also comprises an“enter” user-selectable operator 442 which operates in a manner similarto that of “enter” user-selectable operator 314 described above inrelation to FIG. 3.

In the embodiment of the communication device 400 user interface shownin. FIG. 4, the user is able to enter more detailed information about aparticular event than was the case for the communication device 300 userinterface, shown in FIG. 3. As an example, for a “meal” event the usermay locate the row on the communication device 400 user interface thathas the “meal” 402 indicator. To the right of the “meal” 402 indicatorthere are three event rankings associated with the “meal” event, “light”404, “moderate” 406, and “heavy” 408. These event rankings correspond,generally, to a light meal, a moderate meal, and a heavy meal,respectively.

Although in the embodiment shown in FIG. 4 there are three eventrankings associated with each event, other embodiments may have more orless than three event rankings associated with a particular event.Furthermore, although in the embodiment shown in FIG. 4 certain eventrankings are associated with a particular event, other event rankingsare also possible in other embodiments. For example, although in theembodiment shown in FIG. 4 the event rankings associated with a mealevent are light, moderate, and heavy, in other embodiments the eventranking descriptions may comprise more accurate quantitativedescriptions. For example, in one embodiment, the event rankingsassociated with the meal event could be “less than X grams ofcarbohydrates,” and “more than X grams of carbohydrates.” The effectsfor a particular user of selecting any one of these event rankinguser-selectable operators may be pre-programmed into the closed-loopalgorithm and may, in some embodiments, be modified by a user'sphysician as described above in relation to FIG. 3.

FIG. 5 illustrates an example of a communication device user interfaceaccording to another preferred embodiment. Communication device 500 isprovided with a power source, for example, a battery, independent of theinfusion pump power source. In other embodiments, the communicationdevice 500 may be powered from the infusion pump power source.

Communication device 500 comprises an outer case or housing. This caseor housing may be plastic, metal, or any other suitable material.Situated on the outer housing is the user interface. In the presentpreferred embodiment, communication device 500 user interface comprisesdisplay 502, “select” user-selectable operator 504, “enter”user-selectable operator 506, “cursor left” user-selectable operator508, “cursor right” user-selectable operator 510, “cursor up”user-selectable operator 512, and “cursor down” user-selectable operator514.

Display 502 may comprise any electronic display device for representingimages and text. Display 502 may comprise, for example, a liquid crystaldisplay (“LCD”), a thin film transistor (“TFT”), or any other type ofsuitable display device. Communication device 500 user interface mayenable the user to display particular information on display 502 byselecting the “select” user-selectable operator 504 either alone or incombination with one or more other user-selectable operators.

For example, by initially selecting “select” user-selectable operator504, a menu of events may be displayed to the user, as shown in FIG. 5.The user may then scroll through events on the menu by, for example,using the cursor user-selectable operators 508, 510, 512, and 514. Thecursor highlights the currently selected event. In FIG. 5, the currentlyselected event is the “meal” event. In one preferred embodiment, oncethe desired event is highlighted, the user may then select the “enter”user-selectable operator 506 to proceed, for example, to an eventranking menu, as displayed in display 602, shown in FIG. 6.

FIG. 6 shows an event ranking selection screen on display 502 of thecommunication device 500 user interface. Assuming that the user selectedthe meal event, the event rankings associated with the “meal” event aredisplayed on display 502. In one preferred embodiment, these eventrankings are “light,” “moderate,” and “heavy.” The user may then scrollthrough the displayed event rankings on the menu by, for example, usingthe cursor user-selectable operators 508, 510, 512, and 514. The cursorhighlights the currently selected event ranking. In FIG. 6, thecurrently selected event ranking is the “light” event ranking. In onepreferred embodiment, once the desired event ranking is highlighted, theuser may then select, for example, the “enter” user-selectable operator506 or the “select” user-selectable operator 504 to communicate a signalcorresponding to the selected event ranking to the computing element.

FIG. 7 shows another embodiment of the communication device 500 userinterface wherein more detailed information may be entered regarding themeal event. In the embodiment of the communication device 500 userinterface shown in FIG. 7, particular dietary substances and/orcompounds may be displayed to the user in display 502. The user mayenter an amount for each substance and/or compound. The amount may beexpressed in a suitable unit of measurement, for example in grams. As anexample, the user may use the cursor user-selectable operators 508, 510,512, and 514 to highlight a particular substance or compound. The usermay then select, for example, the “select” user-selectable operator 504to select the substance or compound currently highlighted.

The user may then use, for example, the “cursor up” user-selectableoperator 512 and “cursor down” user-selectable operator 514 to eitherincrease or decrease, respectively, the displayed units of measurement.When the user has entered the dietary information, the user may selectthe “enter” user-selectable operator 506 in order to communicate thedietary information to the computing element.

In yet other preferred embodiments, the user may select foods from foodmenus, as shown in FIG. 8. In one preferred embodiment, a menu ofselectable food types may be displayed to the user in display 502 of thecommunication device 500 user interface after the meal event has beenselected by the user. The user may then use the cursor user-selectableoperators 508, 510, 512, and 514 to highlight a particular food type. InFIG. 8, the user has highlighted the “vegetable” food type. The user maythen select, for example, the “select” user-selectable operator 504 orthe “enter” user-selectable operator 506 in order to select the foodtype currently highlighted.

In one preferred embodiment, when the currently highlighted food type isselected, a menu of foods corresponding to that food type may bedisplayed to the user, as shown in FIG. 9. FIG. 9 shows a selectablemenu of vegetables in display 502. The user may use the cursoruser-selectable operators 508, 510, 512, and 514 to highlight aparticular vegetable. In one embodiment, the user may then use, forexample, the “cursor up” user-selectable operator 512 and “cursor down”user-selectable operator 514 to either increase or decrease,respectively, the displayed number of serving sizes. Once the number ofserving sizes has been selected, the user may then select, for example,either the “enter” user-selectable operator 506 or the “select”user-selectable operator 504 in order to communicate the dietaryinformation to the computing element.

In preferred embodiments of the communication device 500 user interfaceshown in FIGS. 8 and 9, information about a particular food, such as,but not limited to, grams of fat per serving, grams of carbohydrates perserving, and grams of protein per serving, may be stored in a storagedevice located, for example, either in the computing element or withinthe communication device 500 itself. Thus, when a user selects aparticular food and serving size, the dietary information may becalculated automatically by the computing element using the previouslystored information. The closed-loop algorithm may then advantageouslyuse this dietary information to more accurately determine the amount ofinsulin formulation to deliver.

Therefore, embodiments of the invention's infusion pump system andprocess provide a communication device user interface for enteringuser-initiated signals for communication to a computing element withinthe system. The user-initiated signals may be provided as event inputsto a closed-loop algorithm executed by a computing element. When thesystem's sensing device detects changes in a biological state, theclosed-loop algorithm may be programmed to verify that an event input ispresent before delivering an amount of infusion formulation outside ofpre-programmed basal limits.

The amount of insulin formulation to be delivered based on a particularevent may be determined by pre-programmed data concerning the user. Thispre-programmed data may be entered, for example, by the user and/or theuser's physician or other medical professional. Thus, the event inputsprovide safety limits to the amount of infusion formulation delivered inresponse to changes in a particular biological state.

Accordingly, a number of aspects and features of preferred embodimentsof the communication device user interface described above may provideindividually, or may be combined to provide user-initiated signals to acomputing element within an infusion pump system. However, the foregoingdescription of preferred embodiments of the invention has been presentedfor the purposes of illustration and description. It is not intended tobe exhaustive or to limit the invention to the precise forms disclosed.Many modifications and variations are possible in light of the aboveteaching.

For example, the events described above in preferred embodiments of theinvention's system and process are examples of events which may lead tochanges in insulin production by the pancreas of a non-diabetic person,and for which a user-initiated signal may be provided to a closed-loopalgorithm. However, the above-named events should not be considered tobe a limitation on the events which may affect glucose levels in thehuman body, and thus on the events for which a user-initiated signal maybe provided to the closed-loop algorithm by embodiments of theinvention's system and process.

Having disclosed exemplary embodiments and the best mode, modificationsand variations may be made to the disclosed embodiments while remainingwithin the scope of the invention as defined by the following claims.

1-17. (Cancelled)
 18. An infusion pump system for use in delivery of aninfusion formulation, the system comprising: a pump for deliveringmeasured doses of an infusion formulation; a sensing device for sensinga biological state; a computing element communicating with the sensingdevice, the computing element being programmed to receive informationabout the sensed biological state from the sensing device and toregulate the delivery of the infusion formulation in accordance with thereceived information; and a communication device communicating with thecomputing element, the communication device for communicating auser-initiated event signal to the computing element, the user-initiatedevent signal being representative of an event affecting the sensedbiological state; wherein the computing element is further programmed toreceive the user-initiated event signal and initiate a variation in thedelivery of the infusion formulation in accordance with the receiveduser-initiated signal.
 19. The infusion pump system recited in claim 18,wherein the variation in the delivery of the infusion formulation issubstantially contemporaneous with the receipt of the user-initiatedsignal.
 20. The infusion pump system recited in claim 18, wherein thesensing device for sensing the biological state comprises a sensingdevice for sensing a glucose level.
 21. The infusion pump system recitedin claim 18, wherein the computing element is programmed to regulate thedelivery of an insulin formulation.
 22. The infusion pump system recitedin claim 21, wherein the computing element is programmed to initiate anevent-based variation in the delivery of the insulin formulation whichcomprises at least one of an increase in an amount of the deliveredinsulin formulation and a decrease in an amount of the delivered insulinformulation.
 23. The infusion pump system recited in claim 21, whereinthe computing element is further programmed to initiate an event-basedvariation in the delivery of the insulin formulation which comprises abolus delivery of the insulin formulation.
 24. The infusion pump systemrecited in claim 18, wherein the user-initiated event signal isrepresentative of at least one of a meal event, an exercise event, astress event, a sleep event, and a medication event.
 25. The infusionpump system recited in claim 24, wherein the communication devicefurther communicates a user-initiated event ranking signalrepresentative of an event ranking.
 26. The infusion pump system recitedin claim 18, wherein the communication device comprises a plurality ofuser-selectable operators corresponding to respective ones of aplurality of events, the user-selectable operators being selectable forcommunicating to the computing element the user-initiated signal. 27.The infusion pump system recited in claim 18, wherein the communicationdevice comprises a plurality of user-selectable operators correspondingto respective ones of a plurality of event rankings.
 28. The infusionpump system recited in claim 18, wherein the communication devicecomprises a display for displaying events and event rankings affectingthe sensed biological state.
 29. The infusion pump system recited inclaim 28, wherein the communication device further comprises a pluralityof user-selectable operators for selecting particular events and eventrankings on the display and for initiating communication of the signalsto the computing element, the signals representing the events and theevent rankings.
 30. The infusion pump system recited in claim 18,wherein the computing element is further programmed to performdiagnostics in order to verify that the user initiated event signal isconsistent with a detected change in the sensed biological state. 31.The infusion pump system recited in claim 30, wherein the user isalerted when the user initiated event signal is not consistent with thedetected change in the sensed biological state.
 32. The infusion pumpsystem recited in claim 30, wherein the closed-loop algorithm ceases anautomatic control of the infusion pump and returns to a manual operationof the infusion pump when the user initiated event signal is notconsistent with the detected change in the sensed biological state. 33.The infusion pump system recited in claim 25, wherein the computingelement is further programmed to dynamically adjust the amount ofinfusion formulation delivered based on a first user-initiated eventranking signal when a second user-initiated event ranking signal isreceived by the computing element.
 34. The infusion pump system recitedin claim 18, wherein the computing element is further programmed tomaintain a history of user-initiated event signals.
 35. The infusionpump system recited in claim 34, wherein the history is accessible to atleast one of the user and the user's physician.
 36. The infusion pumpsystem recited in claim 18, wherein the pump is an implantable pump.37-41. (Cancelled)